Abiomed ’s Successful Pilot Study Leads to Pivotal Trial

Abiomed shares were down as much as 17% despite announcing positive data for its Impella CP. The Danvers, MA-based company presented the data from the 50-patient pilot trial at the American Heart Association annual conference in Chicago and said because of the favorable data it would now move to a pivotal trial. The results of the FDA STEMI Door-to-Unloading safety and feasibility randomized controlled trial, show unloading the left ventricle with Impella CP for 30 minutes prior to reperfusion in patients presenting with anterior ST-segment elevation myocardial infarction (STEMI) without cardiogenic shock is safe and feasible, when compared to Impella patients reperfused immediately. The results were simultaneously published in Circulation. Unloading first and delaying reperfusion by 30 minutes did not increase 30-day major adverse cardiovascular and cerebrovascular events (MACCE) or infarct size, compared to the immediate reperfusion arm of the trial. Infarct size is a measure of damage to the heart muscle after a heart attack. It is feasible to delay reperfusion in a heart attack (STEMI) patient in a clinical trial, as demonstrated by a 100% adherence to the 30-minute unloading protocol and 100% Impella CP insertion success in both study arms. Unloading the left ventricle for 30 minutes prior to reperfusion appears to reduce infarct size as a percentage of area at risk among patients with a ST sum greater than 6. “If a reduction of infarct size from unload...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news